Commonly assigned U.S. Pat. Nos. 8,652,066; 8,597,183; 8,690,790; 8,602,987; and 8,597,184, the disclosures which are incorporated herein by reference in their entirety, disclose examples of systems and methodologies together with the devices and processing equipment that analyze involuntary reflex cough events and test physiological abnormalities such as stress urinary incontinence.
Commonly assigned U.S. patent application Ser. No. 14/294,747 filed on Jun. 3, 2014, the disclosure which is incorporated herein by reference in its entirety, discloses examples of analysis of the ICR and the effect of respiration on intrinsic sphincters.
Urodynamic tracings from SUI clinical trials showed that inspiration during VC stimulates pulmonary afferent fibers that activate closure of the internal urethral sphincter (IUS). The inventors have filed numerous patent applications and received patents involving the involuntary reflex cough test and analysis of stress urinary incontinence and the LER as related to the effect of inspiration and expiration on IUS and lower esophageal sphincter (LES) activity.
For example, a study has been performed using barium videofluoroscopy study (BSV) of the LES on adult males during VC, LER, breath-hold maneuvers, and normal respiration. Fiber-optic pressure catheters were placed in the LES and IUS and electromyographic (EMG) recording of the right T7-8 intercostals during respiration. The BSV showed closure and relaxation of the LES corresponding to the inspiration and expiration of VC. The LES was patented during the LER and there was closure of LES during the deep inspiration/breath-hold event. Pressure catheters in the LES and IUS showed increased pressure during inspiration and suggests that pulmonary inspiration afferents elicit a patterned reflex motor response in the LES and IUS, referred to as the inspiration closure reflex (ICR).
FIGS. 12A and 12B in the '747 application and in this application disclose clinical examples of the ICR function with a urodynamic (UD) tracing of a series of voluntary and involuntary coughs in a female subject with moderate/severe SUI. This subject had an almost two-fold increase in average IAP with the VC and each cough was preceded by deep inspiration (inhalation). During the VC, it was noted that the deep inspiration that preceded VC activated the ICR and closed the IUS, resulting in a false negative result for SUI in this “moderate to severe” subject. During the involuntary cough event, the IRCT UD tracing revealed multiple urinary leaks, despite the lower average IAP measurements compared with the VC. This suggests that if pulmonary inspiration afferent fibers are activated, these intrinsic sphincters close with every inspiration and release with every expiration. During voluntary maneuvers, such as VC, Valsalva maneuver or sneezing, these intrinsic sphincters release tonicity with expiration. The degree of intrinsic sphincter closure appears to vary with the rate, depth or volutional modification of inspiration. During inspiration, it was noted that it is possible that pulmonary inspiratory afferent fibers to the nucleus tractus solitarius (NTS) may co-activate with the phrenic nucleus, dorsal motor nucleus (DMN) and sacral autonomic nucleus. The LES closure and pressure elevation via the activation of the DMN may coincide with simultaneous activation of the diaphragm.